Research Compliance Specialist - (STA006465)
Under the direction of the Executive or Associate Director, Research Integrity Oversight Office (or IACUC Veterinarian for certain roles), coordinates activities directly related to research compliance, federally mandated oversight committees, and internally funded research programs.
- Serves as a regulatory expert in one or more Responsible
Conduct of Research (RCR) areas, including but not limited to:
research involving human subjects, animal care and use, conflict of
interest, research integrity and/or grant congruency.
- Follows defined processes to ensure institutional and
investigator compliance in one or more of these areas, including
the coordination of review committee function and/or the conduct of
pre- or post-approval monitoring of research.
- Develops and implements guidelines and application processes
for the university research community, develops and delivers
detailed training materials.
- Makes administrative regulatory determinations, and evaluates
investigator response to committee contingencies.
- Serves as a resource for oversight committee members and other
Division of Research offices.
- Reviews grant, contract, and internal award materials for
congruency and/or compliance.
- Assists applicants in coordinating committee review processes
related to funded research.
- Performs other job-related duties as assigned.
Bachelor's Degree and 3 years experience.
Requires a thorough understanding of both theoretical and practical aspects of an analytical, technical or professional discipline; or the basic knowledge of more than one professional discipline. Knowledge of the discipline is normally obtained through a formal, directly job-related 4 year degree from a college or university or an equivalent in-depth specialized training program that is directly related to the type of work being performed.
Requires a minimum of three (3) years of directly job-related experience.
Certification / Licensing:
Certified IRB Professional (CIP), Certified Professional IACUC Administrator (CPIA), Certified Clinical Research Associate (CCRA), Certified Clinical Research Coordinator (CCRC), or Certified Research Administrator (CRA) preferable but not required. If not certified must be willing to sit for certification once qualified.
The position is responsible for conducting congruency reviews of all internally and externally funded research awards and contracts prior to release of award funding to investigators and research teams. The purpose of these reviews is to ensure compliance with regulatory requirements specific to research involving human subjects, animal care and use, conflict of interest an hazardous agents. This role also facilitates institutional processes for the review of Material Transfer and Data Use Agreements, and assists in development of policy and compliance related standard operating procedures. The ideal candidate possesses an educational background in a specific field and at least 3 years' experience in research laboratory, regulatory compliance, or scientific review or writing environment. A working knowledge of federal research regulations (HHS, OLAW, USDA, FDA, OHRP), the ability to understand high level scientific concepts and terminology in research grants and/or papers, and superior written and oral communication skills are prioritized. Strong organizational and time management abilities are also required, as in the ability to proficiently work with multiple teams across the university to accomplish these goals. This position will regularly access reports and metrics from an online protocol system, and may be assigned to coordinate compliance investigations, assemble institutional program descriptions, and/or cross train other Responsible Conduct Research (RCR) areas.
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